The U.S. Food and Drug Administration (FDA) issued a pair of new recall alerts for select extended-release batches of metformin, a popular drug used to control type 2 diabetes.
The drug-safety watchdog published Granules Pharmaceuticals, Inc.’s voluntary recall of their 750mg 100 and 500 count metformin products and Lupin Pharmaceuticals Inc.’s voluntary recall of their 500 and 1000mg metformin products on July 6 and 8, respectively.
Both products were recalled over concern that the metformin contained potentially dangerous levels of N-Nitrosodimethylamine (NDMA), a compound considered carcinogenic in unsafe amounts. Granules Pharmaceuticals and Lupin Pharmaceuticals are the latest in a series of manufacturers of metformin to recall lots of their product due to NDMA concerns.
Granules Pharmaceuticals discovered that “one (1) out of the twelve (12) batches distributed to the US market” contained NDMA levels above the FDA’s acceptable limit.
Consumers should take note that the recalls affect limited batches of the drug. Only the Metformin Hydrochloride Extended-Release Tablets USP 750mg 100 count and 500 count products are affected by this recall. Granules’ other metformin products, including Metformin Hydrochloride Immediate-Release Tablets USP, 500 mg, 850 mg & 1000 mg and Metformin Hydrochloride Extended-Release Tablets USP, 500 mg were not affected by this voluntary recall.
Lupin Pharmaceuticals was also explicit in exactly which lots contained concerning amounts of NDMA. Its voluntary recall was limited to Metformin Hydrochloride Extended-Release Tablets USP, 500mg and 1000mg distributed from November 5, 2018, until May 27, 2020.
Concerned consumers can view the complete recall to see if the lot number matches their current metformin medication from Lupin Pharmaceuticals.
While these voluntary recalls are concerning for patients taking metformin to control their type 2 diabetes, it is important that patients continue to use metformin unless placed on an alternative medication by a medical professional. The American Diabetes Association echoes this sentiment, with Vice President of Medical Information and Professional Engagement Matt Petersen saying, “Patients should continue to take their metformin until their pharmacist supplies a different manufacturer’s product or their doctor prescribes a different treatment.”